At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 10 enrolled

Drug / intervention

Ethanol Lockdrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01865708

NCT01865708Phase 1Completed

Compare CT.gov

Pilot Study of the Safety of a Daily Ethanol Lock for Urinary Catheters in Critically Ill Children

Children's Healthcare of Atlanta·interventional·Posted May 31, 2013·Updated Jun 28, 2018

In Brief

A Phase 1 clinical trial evaluating Ethanol Lock for Complication of Urinary Catheter. Completed, enrolled 10 participants across 1 site.

Detailed Summary

Hypothesis 1: Blood alcohol concentration will be \<25 mg/100ml (equivalent to a blood alcohol concentration of \<0.025%) after a 1 hour urinary catheter ethanol lock. Hypothesis 2: Daily urinary catheter ethanol locks will not result in increased hematuria or increased urinary white cells.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsComplication of Urinary Catheter

CountriesUnited States

Collaborators--

Timeline

Phase 1CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedMay 2013

Enrollment StartJul 2013

Primary CompletionNov 2013

Study CompletionJun 2015

TodayJul 2026

First PostedMay 31, 2013

Enrollment StartJul 1, 2013

Primary CompletionNov 1, 2013

Study CompletionJun 1, 2015

TodayJul 2, 2026

Enrollment to primary: 4 monthsPosted 13.1 years ago

Interventions

Ethanol Lockdrug

Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.